Director, Quality Control

Do you want to contribute to a larger purpose to save the lives of infants in the NICU? This is Prolacta Bioscience's mission! Take a look at this opportunity with our Quality Control team, which is seeking a passionate individual, to fill the role of our Director, Quality Control.

This position is responsible for providing the strategy and direction of Quality Control at Prolacta Bioscience as well as oversight of all laboratory-related activities at the facilities. This includes the Quality Control Operations, Stability, Method Development and Validation, and Clinical Laboratory units at Prolacta Bioscience. The head of Quality Control is responsible for ensuring that all laboratory operations comply with Prolacta Bioscience policies and the requirements of all major regulatory body agencies (e.g. FDA, PMDA, NYSDOH, CDPH, other International regulators, etc.). The Director, Quality Control, along with the Clinical Laboratory Director, oversees the Prolacta Bioscience Clinical Laboratory and ensures compliance with CLIA requirements. This position is part of the site leadership team and serves as a Management Representative.

Who Is Prolacta Bioscience?

We give babies a brighter future by unlocking the biological power of human milk. Established in 1999, Prolacta Bioscience is a privately held life sciences company that has touched the lives of more than 100,000 premature infants globally. Prolacta is the world's leading hospital provider of 100% human milk-based nutritional products. Based in Southern California, we employ more than 300 people globally, many of whom have dedicated their lives to neonatal care.

For more information, please visit www.prolacta.com

How you will contribute
This role will provide you with the opportunity to contribute to the growth of our organization and develop your professional skills by...

* Leading day to day laboratory operations, manufacturing support, and related site quality control activities. The Method Development arm of QC will coordinate with the R&D department regarding required QC activities for developmental products.

Ensuring laboratory operations is supported by sufficient adequately experienced, trained, and equipped Quality Control management and staff to control and assure the purity, efficacy, quality and strength of product manufactured at the site.

Ensuring clinical laboratory is supported by sufficient adequately experienced, trained, and licensed clinical staff for raw material testing to assure the purity, efficacy, quality, and strength of product manufactured at the site.

Coaching, counseling and mentoring staff on issues relating to job activities and career development.

Providing strategy and direction on Quality Control related issues for the site. Independently identifies and initiates functional and cross-functional projects/task teams on a pre-emptive or as needed basis.

Promoting adherence to corporate philosophy and policies through actions and decisions.

Identifying new approaches, systems and/or technologies to improve quality control and productivity for both the functional and business unit. Support initiatives directed at the local level and internationally.

Developing and regularly reporting on metrics to demonstrate levels of quality and compliance and adherence to work plan/business objectives.

Developing and implementing long term goals and objectives for Quality Control Management to meet the demands of the business while maintaining operational quality and compliance of Prolacta Bioscience with applicable local and international policies and government regulations.

Managing cost of testing to meet standard cost targets

Serving as a liaison to Corporate Quality Management team to ensure the consistent application of accepted quality standards.

Providing technical expertise and leadership to the functional area and the business on issues of Quality and Compliance and represent the business on such issues involving GLP/GMP inspections and audits by regulatory agencies and other outside parties.

What you bring to the role

Requirements

BS degree in scientific or healthcare discipline, with 10 years of management experience or MS degree with 5 years of management experience

R. Ph. or Pharm.D. MS or Ph.D. in scientific or healthcare discipline or equivalent combination of education and related experience preferred.

Minimum 10 years management level experience in pharmaceutical regulatory compliance.

Qualifications

• Detailed knowledge of chemistry and manufacturing controls.
• Good general understanding of cross functional groups, i.e. Validation, Process Engineering, R&D, QC, QA, Production, FDA Regulations, GMPs, SOPs
• Knowledge or experience with a CLIA certified laboratory
• Strategic planning experience
• Experience with creating and managing a budget

How Prolacta benefits you

To drive the personal growth and business impact of our employees, we're committed to developing a supportive and enriching culture for everyone. From up to 100% healthcare coverage on your first day and 401(k) match, we value our employees' health and financial wellbeing. We offer four weeks PTO during your first year of employment and support our new parents with a generous time-off program. We encourage employees to participate in our employee affinity groups, take volunteer time off, and provide access to different educational opportunities.

What else do you need to know

Location: City of Industry, and Duarte, CA

Schedule: Monday - Friday 8am to 5pm

Travel: 10% Domestic and International Travel

FLSA: Exempt

Depending on your residential location certain laws might regulate the way Prolacta manages applicant data. California Residents, please review our Privacy Notice for California Employees and Job Applicants for further information, this can be found on Prolacta.com on www.prolacta.com . By submitting your application, you are agreeing and acknowledging that you have read and understand the above notice.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to effectively communicate (e.g., talking/ hearing), walk, sit, use hands and fingers to handle, feel and reach things. The employee is occasionally required to taste, smell, stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.

Sedentary to light work; repetitive motions; pushing; pulling; visual acuity to prepare and analyze data and figures, transcribe, view a computer terminal.

EEO Statement

"Prolacta Bioscience, Inc. is an Equal Employment Opportunity Employer." Prolacta Bioscience, Inc. is committed to a proactive program of affirmative action and diversity development. The Company will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.

#LI-Onsite